XM02, the first granulocyte colony-stimulating factor biosimilar, is safe and effective in reducing the duration of severe neutropenia and incidence of febrile neutropenia in patients with non-Hodgkin lymphoma receiving chemotherapy.
作者： A. Engert , L. Griskevicius , Y. Zyuzgin , H. Lubenau , A. del Giglio
DOI: 10.1080/10428190902756081
关键词: Filgrastim 、 Chemotherapy 、 Internal medicine 、 Medicine 、 Randomized controlled trial 、 Adverse effect 、 Lenograstim 、 Surgery 、 Febrile neutropenia 、 Granulocyte colony-stimulating factor 、 Gastroenterology 、 Neutropenia
摘要: Recombinant granulocyte colony-stimulating factors (G-CSFs) such as filgrastim or lenograstim are being used to treat chemotherapy-induced neutropenia. The aim of the present study was investigate a new G-CSF, XM02, in comparison terms safety and efficacy prevention neutropenia non-Hodgkin-lymphoma (NHL). A total 92 patients receiving chemotherapy were randomised cycle 1 treatment with daily injections (subcutaneous 5 microg/kg/day) XM02 (n = 63) 29) for at least days maximum 14 days. In subsequent cycles, all received XM02. mean duration severe (DSN) 0.5 0.9 filgrastim, respectively (p 0.1055). 1, incidence febrile (FN) 11.1% 20.7% 0.1232). adverse event profile similar between filgrastim. demonstrated equivalent reference medication Treatment is beneficial ameliorating FN NHL chemotherapy. safe well tolerated doses applied this study.
informahealthcare.com参考文章(11)
David C Dale, None, Colony-stimulating Factors for the Management of Neutropenia in Cancer Patients Drugs. ,vol. 62, pp. 1- 15 ,(2002) , 10.2165/00003495-200262001-00001
Andrew Grigg, Philippe Solal-Celigny, Peter Hoskin, Kerry Taylor, Andrew M, Open-label, randomized study of pegfilgrastim vs. daily filgrastim as an adjunct to chemotherapy in elderly patients with non-Hodgkin's lymphoma. Leukemia & Lymphoma. ,vol. 44, pp. 1503- 1508 ,(2003) , 10.1080/1042819031000103953
S. George, F. Yunus, D. Case, B.-B. Yang, J. Hackett, J. E. Shogan, L.A. Meza, T. A. Neumann, B. C. Liang, Fixed-dose pegfilgrastim is safe and allows neutrophil recovery in patients with non-Hodgkin's lymphoma. Leukemia & Lymphoma. ,vol. 44, pp. 1691- 1696 ,(2003) , 10.1080/1042819031000063462
H. Lubenau, A. Sveikata, G. Gumbrevicius, J. Macijauskiene, V. Fokas, S. Kazlauskas, V. Janulionis, Bioequivalence of two recombinant granulocyte colony-stimulating factor products after subcutaneous injection in healthy volunteers. principles and practice of constraint programming. ,vol. 47, pp. 275- 282 ,(2009) , 10.5414/CPP47275
Adi Eldar-Lissai, Leon E. Cosler, Eva Culakova, Gary H. Lyman, Economic Analysis of Prophylactic Pegfilgrastim in Adult Cancer Patients Receiving Chemotherapy Value in Health. ,vol. 11, pp. 172- 179 ,(2008) , 10.1111/J.1524-4733.2007.00242.X
F.A. Holmes, Blinded, Randomized, Multicenter Study to Evaluate Single Administration Pegfilgrastim Once per Cycle Versus Daily Filgrastim as an Adjunct to Chemotherapy in Patients With High-Risk Stage II or Stage III/IV Breast Cancer Journal of Clinical Oncology. ,vol. 20, pp. 727- 731 ,(2002) , 10.1200/JCO.20.3.727
George Demetri, Christopher E. Desch, Philip A. Pizzo, Charles A. Schiffer, Lee Schwartzberg, Mark R. Somerfield, George Somlo, James C. Wade, James L. Wade, Rodger J. Winn, Antoinette J. Wozniak, Antonio C. Wolff, Thomas J. Smith, James Khatcheressian, Gary H. Lyman, Howard Ozer, James O. Armitage, Lodovico Balducci, Charles L. Bennett, Scott B. Cantor, Jeffrey Crawford, Scott J. Cross, 2006 Update of Recommendations for the Use of White Blood Cell Growth Factors: An Evidence-Based Clinical Practice Guideline Journal of Clinical Oncology. ,vol. 24, pp. 3187- 3205 ,(2006) , 10.1200/JCO.2006.06.4451
Matti S Aapro, David A Cameron, Ruth Pettengell, Julia Bohlius, Jeffrey Crawford, Michael Ellis, Nora Kearney, Gary H Lyman, Vivianne C Tjan-Heijnen, Jan Walewski, DC Weber, Christoph Zielinski, European Organisation for Research, EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphomas and solid tumours European Journal of Cancer. ,vol. 42, pp. 2433- 2453 ,(2006) , 10.1016/J.EJCA.2006.05.002
Howard Ozer, James O. Armitage, Charles L. Bennett, Jeffrey Crawford, George D. Demetri, Philip A. Pizzo, Charles A. Schiffer, Thomas J. Smith, George Somlo, James C. Wade, James L. Wade, Rodger J. Winn, Antoinette J. Wozniak, Mark R. Somerfield, , 2000 Update of Recommendations for the Use of Hematopoietic Colony-Stimulating Factors: Evidence-Based, Clinical Practice Guidelines* Journal of Clinical Oncology. ,vol. 18, pp. 3558- 3585 ,(2000) , 10.1200/JCO.2000.18.20.3558
Françoise Martin-Christin, Granulocyte colony stimulating factors: how different are they? How to make a decision? Anti-Cancer Drugs. ,vol. 12, pp. 185- 191 ,(2001) , 10.1097/00001813-200103000-00002